Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia | NCT00284518 | Trialant
CompletedInterventionalPhase 2Updated Dec 17, 2012
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
ClinicalTrials.gov ID
NCT00284518
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
380Actual
Last Update Posted
Dec 17, 2012Estimated
Start Date
Dec 2005
Primary Completion Date
May 2009Actual
Completion Date
May 2010Actual
Brief Summary
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
Benign Prostatic Hyperplasia
botulinum toxin Type A
normal saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lower urinary tract symptoms due to benign prostatic hyperplasia
Enlarged prostate volume by rectal ultrasound
Exclusion Criteria:
Previous prostate surgery
Previous or current diagnosis of prostate cancer
Use of other medications for the treatment of prostatic hyperplasia